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U.S. Department of Health and Human Services

Class 2 Device Recall Lorad

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  Class 2 Device Recall Lorad see related information
Date Initiated by Firm January 14, 2004
Date Posted August 11, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-0149-04
Recall Event ID 29764
510(K)Number K011987  
Product Classification System, X-Ray, Mammographic - Product Code IZH
Product Lorad MIV Platinum Mammograpgy System
Code Information S/N''s :18005960001 to 18010034196
Recalling Firm/
Lorad, A Division of Hologic
36 Apple Ridge Rd
Danbury CT 06810-7301
For Additional Information Contact Luis Nesprido
Manufacturer Reason
for Recall
System failed to meet the mA's accuracy specfications at low mA's values
FDA Determined
Cause 2
Action Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZH and Original Applicant = LORAD, A HOLOGIC CO.